Starkey is adding a Supplier Quality Engineer II to it's Quality team in Operations at it's global headquarters in Eden Prairie, MN. Ideal candidates will have several years of experience with contract manufacturing, working with processes and willing to learn. This position is responsible for the management of suppliers pertaining to hearing aid components and/or finished medical devices. The position will provide Quality Assurance, technical and compliance expertise for conducting supplier audits, qualifying new suppliers, monitoring the performance of current suppliers, and driving quality improvements. This position will include support of supplier corrective actions, nonconformance investigations and assessing the capabilities of new suppliers for product development projects.

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what’s possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and conduct business in more than 100 markets worldwide.

Watch this video to see more of what sets Starkey apart.

https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6

JOB RESPONSIBILITIES/RESULTS

• Manage suppliers of Starkey’s purchased components
  • Drive quality improvement efforts with suppliers
  • Perform assessments of technical and quality capability of new suppliers
  • Assess current and potential suppliers and perform audits as required
  • Drive continuous improvement projects within the supply chain
  • Provide guidance and review of supplier corrective actions and nonconformance investigations

• Ensure that Suppliers execute to Starkey’s expectations
  • Ensure mutual understanding of the specifications and requirements
  • Work with supplier and utilize industry standard quality tools to ensure production capabilities and risk mitigation
  • Assist the sourcing organization in supply risk mitigation efforts

• Assess capabilities of new suppliers
  • Assess potential suppliers quality systems and perform audits as required
  • Provide input to and utilize the supplier scorecard to identify improvement areas
  • Analyze supplier capabilities

• Support supplier management team initiatives and strategies
  • Participate in Supplier risk assessment
  • Participate in supplier scouting activities
  • Participate in commodity team efforts driving improvement in Quality, Total Cost, Velocity, Risk Management and Innovation

• Monitor and maintain QA activities.
  • Write incoming inspection test procedures
  • Disposition nonconforming material
  • Draft and release part qualification report

JOB REQUIREMENTS

Minimum Education, Certification and Experience Requirements

• Education 
  • 4-year Bachelor’s degree in Industrial, Manufacturing, Electrical or Mechanical Engineering
• Experience 
  • Minimum 3 years of experience in a manufacturing or quality engineering preferably including supplier management.

Knowledge / Technical Requirements

• Understanding of ISO 9001 required; Medical device quality systems standards and regulations (ISO 13485, 21 CFR Part 820) desired
• Working knowledge of APQP and PPAP desired
• Understanding of the audit process including planning, execution, reporting and follow-up
• Ability to read print/specifications and be able to communicate these needs to other entities
• ASQ Six Sigma Green Belt desired with ability to lead and execute six sigma projects

Competencies, Skills & Abilities

• Excellent analytical and problem solving skills required
• Excellent communication and people skills required

WORK CONTEXT

Working Conditions

• Normal office conditions; jobholder will be subject to 10% travel, including international.

Equipment Operation 

• Standard PC and office equipment

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